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Review
. 2020 Mar 31;21(7):2435.
doi: 10.3390/ijms21072435.

Clinical-Grade Human Pluripotent Stem Cells for Cell Therapy: Characterization Strategy

Daniela Rehakova  1   2 , Tereza Souralova  2   3 , Irena Koutna  2   3
Affiliations
Review

Clinical-Grade Human Pluripotent Stem Cells for Cell Therapy: Characterization Strategy

Daniela Rehakova et al. Int J Mol Sci. .

Abstract

Human pluripotent stem cells have the potential to change the way in which human diseases are cured. Clinical-grade human embryonic stem cells and human induced pluripotent stem cells have to be created according to current good manufacturing practices and regulations. Quality and safety must be of the highest importance when humans' lives are at stake. With the rising number of clinical trials, there is a need for a consensus on hPSCs characterization. Here, we summarize mandatory and 'for information only' characterization methods with release criteria for the establishment of clinical-grade hPSC lines.

Keywords: cGMP; cell therapy; characterization; clinical; hESC; hPSCs; hiPSC; human embryonic stem cells; human induced pluripotent stem cells; human pluripotent stem cells.

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Conflict of interest statement

The authors declare no conflict of interest.

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